This invention relates generally to the field of devices for the treatment of malformations. In particular, the present invention is a nasal dilator for preventing outer wall tissue of nasal passages of a nose from drawing in during breathing.
A portion of the human population has some malformation of the nasal passages which makes breathing difficult. Example of such malformations are a deviated septum and swelling due to allergic reactions. The lower portion of the nostril, immediately above the entrance to the nostril, is known as a vestibule. The vestibule tapers inwardly to a narrowed neck-like area called the nasal valve. Posterior to the nasal valve the nasal passages widen out again. Nasal obstructions commonly occur at the nasal valve in individuals who have swelling due to allergic reactions, a deviated septum or similar condition, to the point that the nasal valve may be substantially blocked. Commonly, the lateral wall (i.e., the outer wall tissue of the nasal passage) at the nasal valve is loose with the result that the outer wall tissue draws in during the process of inhalation to substantially or completely block the passage of air through the nasal passage.
Blockage of the nasal passages is obviously an inconvenience to persons who experience it. In particular, sustained mouth breathing over a long period of time may cause lung irritation due to the inhalation of foreign particles that would otherwise be filtered if the breath had been passed through the nose. Blockage of the nasal passages is particularly uncomfortable at night, since it is uncomfortable for many people who have such a problem to breathe through the mouth while asleep. Nasal blockage can lead to sleep disturbances, sleep irregularities and/or snoring. In addition, a person with such a condition may wake often because he/she is not inhaling sufficient quantities of oxygen.
The most common approach to a serious and chronic nasal blockage problem as described above is a surgical attempt to correct the malformation of the nasal passages. However, surgery is expensive and may not ultimately correct the problem.
As an alternative to surgery, nasal dilators for aiding breathing through the nose are generally known. U.S. Pat. No. 4,414,977 to Rezakhany discloses one such nasal dilator. The nasal dilator includes generally elongated top and bottom rings which are spaced apart and connected together by a rear strut and a front strut. The front strut is longer than the rear strut and includes a bend therein formed at a position close to the front end of the bottom ring. When in place in the nasal passage, the top ring fits in the nasal valve within the nostril to prevent the tissue from being drawn in during inhalation, and to reduce extra flow resistance during exhalation. The bottom ring fits above the entrance to the nostril and serves to stabilize the position of the top ring within the nasal passage. One of these nasal dilators must be inserted into each nasal passage to provide unobstructed breathing.
However, these nasal dilators are not always effective since they are uncomfortable to wear. Because the nasal dilators must be inserted within the nasal passages they may cause irritation and itching. In addition, these nasal dilators must be custom-made to fit each nasal passage of an individual.
Another nasal dilator is disclosed in the U.S. Pat. No. 1,292,083 to Sawyer. This nasal dilator includes pads of adhesive material to which are attached metal loops. The pads are applied to the exterior surface of the nose above the nostrils. Once the pads are affixed, a dilating member is connected with each of the loops. The dilating member consists of a metal wire that provides a spring force which is directed outwardly or upwardly when hooked ends of the dilating member are engaged with the loops of the pads. A further nasal dilator is disclosed in the U.S. Pat. No. 1,950,839 to Chirila. This nasal dilator is similar to that of Sawyer but employs suction cups to secure a dilating member to the exterior surface of the nose.
These nasal dilators are not always effective in insuring free breathing because of their multiple element configurations that are designed to be assembled and then disassembled. Because these dilators are meant to be readily assembled and disassembled, the dilating members can easily become disengaged from the elements (i.e., the pads in Sawyer and the suction cups in Chirila) that secure the dilating members to the exterior of the nose. This unwanted disengagement of the elements could result in injury to the face or eyes of the wearer of the nasal dilators. Injury to the face and eyes is particularly likely during sleep, when the dilators are most likely worn since the wearer of the dilators, during any rolling over or the like, has little conscious control or awareness of the assembled or disassembled state of the dilators.
A still further nasal dilator is disclosed in the International Application Published Under The Patent Cooperation Treaty WO 92/22340 to Johnson. This nasal dilator comprises a truss member that includes a flexible strip of material having a first end region, a second end region and an intermediate segment. The first and second end regions are adapted to engage the outer wall tissue of first and second nasal passages of the nose and are secured thereto via an adhesive substance. The intermediate segment traverses the bridge of the nose. The truss member further includes resilient bands that are secured to the strip of material by way of strips of double sided adhesive foam tape. The resiliency of the bands acts to stabilize the outer wall tissue and thereby prevents the outer wall tissue of the nasal passages from drawing in during breathing.
In the International Application, a padded element is secured to the median of the intermediate segment of the strip of material via the adhesive substance. The padded element creates an absorbative adhesive void between the truss member and the bridge of the nose. The absorbative adhesive void absorbs moisture due to perspiration, or the like. The adhesive void also allows for redirection of resulting forces in the truss member caused by forces (which push the skin of the nose up along the outer wall cartilage of the nose) occurring when one side of the nose or face of the wearer is distorted from its normal or relaxed position, by such actions as wiping the nose or face, facial gestures or sleeping with part of the nose or face against a pillow. The absorbative adhesive void allows for transference (i.e., redirection) of these resulting distortion forces in the truss member, which are imparted to the truss member via contact with an object, facial gestures, etc., by allowing that portion of the nasal dilator with the adhesive void to rise off of the bridge of the nose.
By allowing the nasal dilator to rise off the nose bridge, the adhesive void substantially reduces the transference of truss member motion, from the end of the truss member upon which distortion forces are acting, along the truss member over the bridge of the nose, and to the opposite end of the truss member (and thereby to the skin on the opposite side of the nose), that would occur absent the adhesive void (i.e., if the truss member were adhesively secured to the bridge of the nose). This transference of distortion forces from one end of the truss member, along the truss member and to the other end of the truss member may cause wearer skin distortion due to increased shear and peel forces at the adhesive interface to the skin. This skin distortion may be uncomfortable to some wearer's. Further, by allowing the nasal dilator to rise off the nose bridge, the adhesive void eliminates upward pulling forces on the skin of the bridge of the nose, that might otherwise occur if the intermediate segment of the strip of material were adhesively secured to the nose bridge. However, the raising and lowering of the adhesive void (i.e., padded element) at the bridge of the nose stimulates the skin on the nose bridge, which some wearer's of the nasal dilator perceive as an irritating itch. This itching sensation felt by some wearer's may cause some wearer's to perceive the dilator as uncomfortable.
It is evident that there is a continuing need for improved nasal dilators for preventing outer wall tissue of nasal passages of a nose from drawing in during breathing. Specifically, there is a need for a nasal dilator that can provide effective relief without the need of inserting an object within the nasal passage. Moreover, there is a need for a nasal dilator that can be reliably worn at night when the nasal blockage problem is most acute and most uncomfortable. In addition, there is a need for a nasal dilator that can be reliably worn through extended therapeutic periods. The nasal dilator should be of efficient design and relatively uncomplicated. In addition, the nasal dilator should provide effective stabilization of the outer wall tissue of the nasal passages to provide effective relief from nasal blockage during inhalation. Moreover, this effective stabilization should be provided without undue discomfort to the wearer.